Total Haemolytic Complement

GUDID 05051700010269

THE BINDING SITE GROUP LIMITED

Total complement activity (CH50) IVD, kit, precipitation/immunodiffusion
Primary Device ID05051700010269
NIH Device Record Key01ddc073-d32a-4510-acc8-58e88ca5983a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Haemolytic Complement
Version Model NumberRC001.1
Company DUNS347045614
Company NameTHE BINDING SITE GROUP LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401214569500
Emailinfo@bindingsite.co.uk

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105051700010269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAEComplement C9, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Total Haemolytic Complement ]

05051700010283RC001.3
05051700010276RC001.2
05051700010269RC001.1

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